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Responsible innovation in human germline gene editing : background document to the recommendations of ESHG and ESHRE

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Abstract
Technological developments in gene editing raise high expectations for clinical applications, including editing of the germline. The European Society of Human Reproduction and Embryology (ESHRE) and the European Society of Human Genetics (ESHG) together developed a Background document and Recommendations to inform and stimulate ongoing societal debates. This document provides the background to the Recommendations. Germline gene editing is currently not allowed in many countries. This makes clinical applications in these countries impossible now, even if germline gene editing would become safe and effective. What were the arguments behind this legislation, and are they still convincing? If a technique could help to avoid serious genetic disorders, in a safe and effective way, would this be a reason to reconsider earlier standpoints? This Background document summarizes the scientific developments and expectations regarding germline gene editing, legal regulations at the European level, and ethics for three different settings (basic research, preclinical research and clinical applications). In ethical terms, we argue that the deontological objections (e.g., gene editing goes against nature) do not seem convincing while consequentialist objections (e.g., safety for the children thus conceived and following generations) require research, not all of which is allowed in the current legal situation in European countries. Development of this Background document and Recommendations reflects the responsibility to help society understand and debate the full range of possible implications of the new technologies, and to contribute to regulations that are adapted to the dynamics of the field while taking account of ethical considerations and societal concerns.
Keywords
EMBRYONIC STEM-CELLS, MITOCHONDRIAL REPLACEMENT THERAPY, MEDICALLY ASSISTED REPRODUCTION, PHOSPHOLIPASE-C ZETA, IN-VITRO, OOCYTE ACTIVATION, DNA DISEASE, GENOME, MOUSE, GENERATION

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MLA
De Wert, Guido, et al. “Responsible Innovation in Human Germline Gene Editing : Background Document to the Recommendations of ESHG and ESHRE.” EUROPEAN JOURNAL OF HUMAN GENETICS, vol. 26, no. 4, 2018, pp. 450–70, doi:10.1038/s41431-017-0077-z.
APA
De Wert, G., Heindryckx, B., Pennings, G., Clarke, A., Eichenlaub-Ritter, U., van El, C. G., … Cornel, M. C. (2018). Responsible innovation in human germline gene editing : background document to the recommendations of ESHG and ESHRE. EUROPEAN JOURNAL OF HUMAN GENETICS, 26(4), 450–470. https://doi.org/10.1038/s41431-017-0077-z
Chicago author-date
De Wert, Guido, Björn Heindryckx, Guido Pennings, Angus Clarke, Ursula Eichenlaub-Ritter, Carla G van El, Francesca Forzano, et al. 2018. “Responsible Innovation in Human Germline Gene Editing : Background Document to the Recommendations of ESHG and ESHRE.” EUROPEAN JOURNAL OF HUMAN GENETICS 26 (4): 450–70. https://doi.org/10.1038/s41431-017-0077-z.
Chicago author-date (all authors)
De Wert, Guido, Björn Heindryckx, Guido Pennings, Angus Clarke, Ursula Eichenlaub-Ritter, Carla G van El, Francesca Forzano, Mariëtte Goddijn, Heidi C Howard, Dragica Radojkovic, Emmanuelle Rial-Sebbag, Wybo Dondorp, Basil C Tarlatzis, and Martina C Cornel. 2018. “Responsible Innovation in Human Germline Gene Editing : Background Document to the Recommendations of ESHG and ESHRE.” EUROPEAN JOURNAL OF HUMAN GENETICS 26 (4): 450–470. doi:10.1038/s41431-017-0077-z.
Vancouver
1.
De Wert G, Heindryckx B, Pennings G, Clarke A, Eichenlaub-Ritter U, van El CG, et al. Responsible innovation in human germline gene editing : background document to the recommendations of ESHG and ESHRE. EUROPEAN JOURNAL OF HUMAN GENETICS. 2018;26(4):450–70.
IEEE
[1]
G. De Wert et al., “Responsible innovation in human germline gene editing : background document to the recommendations of ESHG and ESHRE,” EUROPEAN JOURNAL OF HUMAN GENETICS, vol. 26, no. 4, pp. 450–470, 2018.
@article{8600067,
  abstract     = {{Technological developments in gene editing raise high expectations for clinical applications, including editing of the germline. The European Society of Human Reproduction and Embryology (ESHRE) and the European Society of Human Genetics (ESHG) together developed a Background document and Recommendations to inform and stimulate ongoing societal debates. This document provides the background to the Recommendations. Germline gene editing is currently not allowed in many countries. This makes clinical applications in these countries impossible now, even if germline gene editing would become safe and effective. What were the arguments behind this legislation, and are they still convincing? If a technique could help to avoid serious genetic disorders, in a safe and effective way, would this be a reason to reconsider earlier standpoints? This Background document summarizes the scientific developments and expectations regarding germline gene editing, legal regulations at the European level, and ethics for three different settings (basic research, preclinical research and clinical applications). In ethical terms, we argue that the deontological objections (e.g., gene editing goes against nature) do not seem convincing while consequentialist objections (e.g., safety for the children thus conceived and following generations) require research, not all of which is allowed in the current legal situation in European countries. Development of this Background document and Recommendations reflects the responsibility to help society understand and debate the full range of possible implications of the new technologies, and to contribute to regulations that are adapted to the dynamics of the field while taking account of ethical considerations and societal concerns.}},
  author       = {{De Wert, Guido and Heindryckx, Björn and Pennings, Guido and Clarke, Angus and Eichenlaub-Ritter, Ursula and van El, Carla G and Forzano, Francesca and Goddijn, Mariëtte and Howard, Heidi C and Radojkovic, Dragica and Rial-Sebbag, Emmanuelle and Dondorp, Wybo and Tarlatzis, Basil C and Cornel, Martina C}},
  issn         = {{1018-4813}},
  journal      = {{EUROPEAN JOURNAL OF HUMAN GENETICS}},
  keywords     = {{EMBRYONIC STEM-CELLS,MITOCHONDRIAL REPLACEMENT THERAPY,MEDICALLY ASSISTED REPRODUCTION,PHOSPHOLIPASE-C ZETA,IN-VITRO,OOCYTE ACTIVATION,DNA DISEASE,GENOME,MOUSE,GENERATION}},
  language     = {{eng}},
  number       = {{4}},
  pages        = {{450--470}},
  title        = {{Responsible innovation in human germline gene editing : background document to the recommendations of ESHG and ESHRE}},
  url          = {{http://dx.doi.org/10.1038/s41431-017-0077-z}},
  volume       = {{26}},
  year         = {{2018}},
}

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